Optimizing primary vaccination schedule for premature infants

Completed

• Conditions: immunogeniciteit bij prematuren ten aanzien van respons op de vaccinaties uit het RVP en de rotavirusvaccinatie; antibody's; immunogenicity; 10019815

• Registration Number: NL-OMON44869
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-19
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 298

Inclusion Criteria

preterm infants, stratified in 3 groups (<28 weeks, 28-32 weeks or 32-36 weeks GA), included via RIVAR study

Exclusion Criteria

not willing to let take blood

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>* Antibody levels against the regular NIP vaccine components (DTaP, IPV, HIb,<br /><br>HepB and PCV10) at 5 and 12 month of age in preterm infants.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints<br /><br>* Levels of maternal antibodies at 6 weeks of age<br /><br>* Cellular immunity at 12 month<br /><br>* Timelines of NIP vaccines<br /><br>* Tolerability and vaccine side effects<br /><br>* Rotavirus seroconversion rates and antibody levels at 5 an 12 month of age<br /><br>among those vaccinated</p><br>